Comfort of Patients Under Non Invasive Ventilation According to the Mask (ComPaNIV)

Comparison of the Comfort of Patients Under Non-invasive Ventilation According to the Use of a Sub Nasal Mask Versus an Oronasal Mask

A sub-nasal mask with a skirt that fits the nostrils and with a dedicated port for the nasogastric tube has recently been introduced. This interface has never been compared to nasal-oral masks. We hypothesise that such a sub-nasal mask increases comfort compared to a conventional naso-oral mask. The primary objective is to compare the comfort of the sub-nasal mask with that of a standard naso-oral mask.

Study Overview

• Status: Not yet recruiting
• Conditions: COPD Exacerbation; Acute Respiratory Failure; Hypercapnia; Hypoventilation Obesity Syndrome
• Intervention / Treatment: Device: mask

Detailed Description

Non-invasive ventilation (NIV) is a first-line treatment for many conditions encountered in the ICU. This technique requires training of heath professionals, appropriate equipment, optimisation of ventilator settings and good cooperation from the patient. Indeed, NIV failures lead ton invasive mechanical ventilation, thus increasing morbidity and mortality. These failures are favoured by the patient's poor tolerance to NIV. The success of the treatment depends greatly on the patient's compliance and comfort. The choice of the mask is therefore essential. There are different types of interface, such as the full-face helmet, the face mask, the nasal-oral mask or the nasal mask. The nasal-oral mask rmains the most commonly used interface. Recommendations emphasise the importance of choosing a mask that is the right size and best tolerated by the patient. Despite benefits of NIV, there are a number of potential complications: skin lesions at pressure points, particulaly at the nasal bridge, gastric distension, barotrauma, haemodynamic effects of positive presure ventilation, claustrophobia, anxiety, difficulty in speaking and eating, dry eyes, patient-ventilator asynchrony. Some of these complications depend on the type of mask used. a sub-nasal mask with a skirt that fits the nostrils and a dedicated port for the nasogastric tube has recently been introduced. To our knowledge, this interface has never been compared to commercially avaible nasal-oral masks.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Christophe CARPENTIER, MD; Phone Number: 33 0145217138; Email: christophe.carpentier@aphp.fr
• Study Contact Backup: Name: Tai PHAM, MD; Phone Number: +33 0145217138; Email: tai.pham@aphp.fr

Study Locations

• France
  • Créteil, France
    • Hôpital Henri Mondor - Réanimation/ Unité de Surveillance Continue
    • Contact: Armand Mekontso Dessap, MD
  • Le Kremlin-Bicêtre, France, 94270
    • CHU Bicêtre - Unité de Soins Intensifs Pneumologique
    • Contact: Laurent SAVALE, MD; Email: Laurent.savale@aphp.fr
  • le Kremlin Bicetre, France, 94270
    • CHU Bicêtre - USC
    • Contact: Christophe CARPENTIER, MD; Phone Number: 33 0145217138; Email: christophe.carpentier@aphp.fr
    • Contact: Tai PHAM, MD; Email: tai.pham@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Adult patients hospitalized in intensive care, continuous monitoring unit or pulmonary intensive care with an indication for NIV.

Description

Inclusion Criteria:

Indication of NIV, carried out by the physicians in charge of the patient, among the following:

• COPD exacerbation
• Hydrostatic acute pulmonary edema
• Acute Chest Syndrome with Hypercapnia in Sickle Cell Patients
• Post-extubation, planned in a patient at risk or recovering from extubation failure
• Hypoventilation-obesity syndrome

Exclusion Criteria:

Formal contraindication to NIV among:

• Indication for orotracheal intubation at the outset
• Non-cooperative, agitated, opponent of the technique
• Coma
• Respiratory exhaustion
• Shock, severe ventricular arrhythmias, immediate aftermath of cardiac arrest
• Undrained pneumothorax, blowing chest wound
• Upper airway obstruction (except sleep apnea, laryngotracheomalacia)
• Uncontrollable vomiting
• Upper gastrointestinal bleeding
• Measure of protection of justice
• Facial deformity
• Dying or palliative care patient
• Pregnancy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 to 10 self assessment scale	Comfort will be assessed by a numerical self-assessment scale from 0 to 10.	throughout the study (an average of 10 months)

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects who prefer one type of mask over the other	throughout the study (an average of 10 months)
Percentage of leakage volume compared to the tidal leakage volume	throughout the study (an average of 10 months)
Dyspnea	throughout the study (an average of 10 months)
Number of interventions on mask position by nurses during NIV session	throughout the study (an average of 10 months)
Number of side effects	throughout the study (an average of 10 months)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Christophe CARPENTIER, MD, Assistance Publique - Hôpitaux de Paris, Hôpital Bicêtre

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Non-invasive ventilation; Comfort; Acute respiratory failure
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Overnutrition; Nutrition Disorders; Overweight; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Obesity; Sleep Apnea, Obstructive; Respiratory Insufficiency; Hypoventilation; Obesity Hypoventilation Syndrome; Hypercapnia
• Other Study ID Numbers: APHP231673; 2023-A02093-42 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No